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The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities

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2009 J. Radiol. Prot. 29 507

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IOP PUBLISHING JOURNAL OF RADIOLOGICAL PROTECTION
J. Radiol. Prot. 29 (2009) 507–517 doi:10.1088/0952-4746/29/4/005

The effects of the Brazilian regulatory inspection


programme on nuclear medicine facilities
C E G R Alves1 , E M Azevedo1 , L V de Sá2 , L A R da Rosa2 ,
L C G Mendes1 , W F L França1 , R F Gutterres1 and M Gonçalves1
1
Comissão Nacional de Energia Nuclear—CGMI/CNEN, Rua General Severiano 90, 22290-901,
Rio de Janeiro, Brazil
2 Instituto de Radioproteção e Dosimetria—IRD/CNEN, Avenida Salvador Allende s/n,

22780-160, Rio de Janeiro, Brazil

E-mail: telo@xexeu.org (M Gonçalves)

Received 3 December 2008, in final form 30 June 2009, accepted for


publication 8 July 2009
Published 18 November 2009
Online at stacks.iop.org/JRP/29/507

Abstract
This paper aims to demonstrate the importance of the regulatory inspections
carried out by the Brazilian regulatory body in the area of nuclear medicine.
The main aspects observed during the inspections are presented as well as the
time evolution of the non-compliances, according to their occurrence by type.
We also evaluate factors concerning the working of the nuclear medicine facility
responsible for solving the non-compliances. The results suggest a decrease of
occurrence of non-compliances with time that can be related to the strictness
of the inspections and the awareness of the personnel in the nuclear medicine
facilities. An analysis of radiation dose exposure levels for the professionals
involved in nuclear medicine was carried out; although dose values are below
regulatory dose limits, their occurrence is not decreasing satisfactorily. Results
indicate the need for staff training and commitment of the responsible nuclear
medicine facility staff to the radiological protection procedures. Our results
also emphasise the importance of continuous coercive actions to improve the
level of radiological protection in nuclear medicine facilities in compliance with
the standards established by the national regulatory authority and international
recommendations.

1. Introduction

The Brazilian nuclear regulatory body, namely the National Commission of Nuclear Energy
(CNEN), following international recommendations [1–5], is the organisation in charge of the
licensing and control of nuclear and radioactive practices and installations in the country.
Within its organisational structure there is a division in charge of groups that regularly inspect

0952-4746/09/040507+11$30.00 © 2009 IOP Publishing Ltd Printed in the UK


508 C E G R Alves et al

and evaluate licensed installations in different industrial and medical fields. In this context,
there is a trained group specifically dedicated to inspecting nuclear medicine facilities.
During the licensing process [6, 7], a prior inspection is performed to guarantee that the
construction and working area classification comply with the previously approved project that
was submitted to CNEN as part of the process of obtaining the first authorisation to operate.
On-site inspections of the installation take place every 2 years during which several radiological
protection aspects are analysed according to a 126-item checklist, and their compliance with
national regulations and standards is verified.
Among the large variety of items evaluated during inspections, four main categories have
been chosen due to their major impact on the radiological protection of a nuclear medicine
facility. As a direct consequence of the doses delivered to patients, the occupational doses
to workers, the dose to the public in general and the environmental impact are also analysed.
The doses to patients are not analysed in this work, since they are outside the scope of CNEN
inspections. Some efforts have been made since 2008 to evaluate and establish guidance levels
in nuclear medicine procedures around the country.
This work was developed with the aim of analysing the effectiveness of inspections of
nuclear medicine facilities in Brazil in the period from 1996 to 2006 [8].

2. Non-compliances of interest

The four items chosen for analysis in the present work were obtained over a long period, from
1996 to 2006, to guarantee the continuity of inspection in each facility and representative non-
compliance evaluation statistics. These items are:

• Surface contamination and exposure records: to verify the proper manipulation of


radioactive material and shielding conditions.
• Surface contamination and survey meter calibration: to verify the proper operation
conditions for the equipment.
• Radionuclide dose calibrator and gamma camera quality control programme: to guarantee
the doses delivered to patients and the quality of images.
• Radioactive material manipulation procedure: to verify contamination of the workplace
and workers.
These groups of non-compliances are detailed below.

2.1. Surface contamination and exposure rate records


Surface contamination and exposure data give an idea about the extent of the commitment of
the facility’s staff to radiological protection procedures. According to Brazilian standards [9]
these data should be taken on a daily basis. When an incomplete record is found during
inspections, it is associated with an increase in the health risk to public and workers as well
as being a potential environmental hazard. Because unsealed sources are in use, contamination
is considered common in nuclear medicine facilities; however, it should be kept under control
and the maintenance of the related data becomes important in order to avoid the spread of
radioactive contamination.
Additionally, the exposure rate records are important for evaluating shielding efficiency,
to realise the optimisation process of occupational doses and to investigate some events, like
accidents or incidents, preventing unnecessary exposure. The complete absence of such records
was, unfortunately, observed during some inspections.
The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 509

2.2. Surface contamination and exposure rate survey calibration certificates


According to the Brazilian regulations [9], a nuclear medicine facility must possess sufficient
backup survey dosimeters to be able to carry out radiation measurements at any time, even when
some of their equipment is being calibrated or is out of operation. Moreover, these instruments
must have their calibration certificates updated and the calibration laboratory must be certified
and audited by CNEN. Additionally, a set of control tests should be carried out in order to
guarantee proper routine monitoring of the operation of instruments.
In order to guarantee that the installation quality assurance programme is performed
properly, the calibration certificates are checked and, if they have not been updated, a non-
compliance is added to the inspection report.

2.3. Dose calibrator and gamma camera quality control programme


Quality control programmes for the equipments used in a nuclear medicine facility are of
great importance for their proper operation, contributing to adequate radiological protection of
patients. One of the most important responsibilities of the radiation protection officer [10, 11]
is to guarantee that all equipment employed in patient diagnosis and treatment is working
properly, so its performance must be evaluated and optimised in order to deliver to the patient
the lowest dose able to provide a reliable diagnosis.
Additionally, in order to ensure that the administered dose is that prescribed by the nuclear
physician, the operation of the radionuclide dose calibrator should be verified frequently, since
small deviations in the activity response can result in an inaccurate diagnosis and require a
repetition of the examination with a dose increment to the patient and workers.
The regular control of scintillation cameras to check the uniformity and adequate resolution
of the images they generate, as well as their sensitivity in detecting the radiopharmaceutical
administered to the patient, is of great importance for good medical practice as well.

2.4. Radioactive material manipulation procedure


Besides the above-listed verifications, the inspectors also perform an on-site worker
contamination survey. Measurements in every controlled area in the facility are carried out and
all workers who are manipulating radioactive products during the inspection are investigated,
with the goal of evaluating the contamination on their hands, feet and clothes. These evaluations
also provide a good idea of whether the workers are trained in and committed to radiological
protection procedures during the different stages of manipulation of radioactive isotopes.

2.5. Persistence of non-compliances


During the on-site inspection the non-compliance items from the last inspection are reviewed
and the effectiveness of implementing the required solutions is checked by the radiation
protection officer. When a non-compliance is not solved, it is marked as a persistent one
and coercive actions are re-enforced by the regulatory body in order to keep the situation
under control. According to the radiological risk associated with that non-compliance the
facility licence can be revoked and the nuclear medicine service closed by the law enforcement
agencies.
In this work we define an inspection persistent level, TR , for the facility in terms of the
percentage of persistent non-compliances related to the four items considered in this work. TR
is important for the inspection programme since it is a direct measure of the efficacy of the
510 C E G R Alves et al

programme and the necessary regulatory enforcement as well. Then:


R
TR = × 100, (1)
NR
where N R is the total number of nuclear medicine facilities that present at least one non-
compliance and R is the number of persistent non-compliances during an inspection cycle
(usually a 2-year period).

3. Annual staff effective dose

According the Brazilian regulations all professionals who work with radioactive materials
should be individually monitored. The Brazilian Radiation Protection and Dosimetry Institute
in Rio de Janeiro has created a national database that controls this individual monitoring. The
database system considers the following approaches related to occupational doses:
• Annual effective dose limits adopted by the regulatory authority [9].
• An anytime effective dose of 4 mSv as a threshold for investigating occupational high dose
values.
• An anytime effective dose of 100 mSv to start in vitro investigation.
The Brazilian regulatory authority, CNEN, has adopted the BSS-115-IAEA recommended
dose limit [1, 2] since 2005. As a consequence, an investigation level of an effective dose of
1.0 mSv/month or a value of 6.0 mSv/year for workers in routine procedures has been adopted.
During the inspections, the occupational doses are investigated and, if some of them are higher
than this limit, it is checked whether the investigation was carried out by the installation’s
personnel and if the proposed solutions have been implemented. As the new limits were
adopted in 2005, facilities are now adjusting their optimisation process accordingly.
When the effective dose limits are outdated or a high dose value is observed, higher than
4 mSv, the radiation protection officer must send to CNEN an investigation report explaining
the causes of this dose value and the new procedures adopted to prevent further events. In the
case of doses above 100 mSv, besides the investigation report, an in vitro study must be carried
out.

4. Results

In this section the main data collected during the Brazilian regulatory inspection programme
for a 10-year period, from 1996 to 2006, are presented. The time evolution of the number of
non-compliances per installation is also showed, as well as the number of inspections carried
out and the number of persistent non-compliances.
After a positive outcome as a result of the sanctions introduced in the early years of this
study, in 2001 a quality assurance programme was introduced for the regulatory body and the
inspectors were given extensive training to carry out their work under this new vision. Since
then, some new items of compliances have been introduced in the checklist and, as result, an
increase in non-compliances was observed in 2002.

4.1. Non-compliance frequencies


To analyse the non-compliance of interest the average non-compliance frequency, f i (%), is
defined as follows:
νi
fi (%) = × 100, (2)
S
The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 511

Figure 1. Frequency of nuclear medicine installations that have non-compliances associated with
surface contamination records (solid bars) and exposure records (empty bars).

where νi is the number of facilities presenting the non-compliance of interest and S is the total
number of facilities inspected per year. The term f i indicates the percentage of installations
presenting this non-compliance in a certain year. The index i is related to one of the four
non-compliances of interest described above. Namely,
i = 1: surface contamination and exposure records;
i = 2: surface contamination and survey meter calibration certificates;
i = 3: radionuclide dose calibrator and gamma camera quality control programmes; and
i = 4: radioactive isotope manipulation procedures.
In figure 1, f 1 is displayed as a function of the inspection year. It can be observed that the
non-compliances decreased considerably from 1996 to 2001, oscillating around a frequency
of 30%. The solid bars are related to surface contamination and empty bars to exposure
records. Once this non-compliance has been directly related to the lack of a culture of
executing the measurements or, in the worse case, to a total non-execution of the procedure, a
large frequency of 30% can be associated with the absence of training in preparation for the
professionals to execute and register the measurements. In these cases, the regulatory authority
should act coercively by limiting the installation licensing conditions, by reducing the period
of authorisation to operate as well as by restricting the amount of radioactive isotopes to be
furnished to the installation.
It can be observed that there was a rapid decrease in exposure measurements and records
between 1996 and 2001. After that, with an exception in 2002, an almost constant value of
around 20% is obtained. This value is still considered too high, and it is also related to the
safety culture and the commitment of the radiation protection officer to keeping records of all
measurements.
In figure 2 f 2 , the non-compliances associated with updated calibration certificates of the
instruments, surface contamination meters (solid bars) and exposure meters (empty bars) are
presented. It can be observed that, despite the increasing pattern from 1996 up to 1998, these
non-compliances decreased until 2001, indicating an effective response to inspections. After
2001 another frequency increase can be observed that may be explained by the limited number
of certified calibration laboratories able to perform instrument calibrations in the country. This
problem persisted until the period 2005–2006, when a constant value of almost 20% of the
installations still presented this non-compliance.
512 C E G R Alves et al

Figure 2. Frequency of contamination instruments (solid bars) and survey monitors (empty bars)
presenting out of date calibration certificates.

Figure 3. Frequency of deficient radionuclide dose calibrators (solid bars) and inappropriate gamma
camera quality control (empty bars), as a function of the year of inspection.

Non-compliances associated with the quality control of the radionuclide dose calibrator
are presented as solid bars in figure 3. Although the coercive regulatory actions and a large
number of training courses for nuclear medicine staff were available in this field in Brazil,
this special item presents a small level of improvement in radiological protection since around
35% of the facilities have an inefficient quality control programme. This problem raises a very
important radiation protection point, because since 1996 the radiation protection officer does
not seem to have been concerned about quality control procedures for equipment. Once the
accuracy in the activity measurement is related to the patient dose and, consequently, to the
radiological protection of the patient, new and strong enforcement actions should be planned
by the regulatory authority to reduce the frequency of this non-compliance.
The frequency of non-compliance associated with gamma camera quality control, empty
bars in figure 3, is evidence that the quality control programmes in a general way have been
neglected by the radiation protection officer and nuclear medicine physicians. Since dose
control and the checking of all image tools are requirements for an adequate and safe diagnosis,
they are peremptory controls in a nuclear medicine facility. A way to improve the facility
control procedures is to support governmental organisations like the Brazilian Institute of
Radiation Protection and Dosimetry in providing training courses in different regions all over
the country with the objective of helping the majority of facilities, emphasising the importance
of quality control and assurance programmes, to offer a good quality service to the population.
The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 513

Figure 4. Non-compliance frequency related to radioactive isotope manipulation procedures as a


function of the inspection year.

The non-compliance frequency associated with manipulation procedures involving


radioactive material is illustrated in figure 4. Although high, the values shown in the figure
can be related to the difficulty of dealing with unsealed radioactive sources. A low level
of contamination may be expected in some specific controlled areas like the radiopharmacy
room in every nuclear medicine facility, but the introduction of courses offering training in
this routine could improve staff performance. As observed during the inspections, those
installations that have regular training and professional meetings to discuss the accidents and
incidents related to manipulation of radioactive materials are introducing improvements to the
routine and are working better.
An important remark is that the data are obtained by inspectors executing measurements
during on-site visits related to contamination. The instruments used to carry out this task belong
to the regulatory authority and have an independent calibration factor enabling a comparison of
results so obtained with those measured with the facility’s equipment.
By setting all non-compliances together it is possible to analyse their time evolution for a
10-year period of on-site inspections. Thus, we define a non-compliance index, F(%), as:
1 n
F(%) = fi , (3)
n i=1
where n = 4 is the total number of non-compliances of interest, and f i is the frequency of the
non-compliance i .
This index can be considered as the average percentage of nuclear medicine installations
that presents all non-compliances of interest. Alternatively, F can be explained as the mean
number of non-compliances that are present in every nuclear medicine facility. Both analyses
indicate that the Brazilian regulatory inspections programme is efficient in keeping the non-
compliances frequency low, since F has remained at around 30% over the last 5 years, as
presented in figure 5. Another conclusion is, certainly, is that some efforts are still necessary to
reduce this percentage.

4.2. Persistence of non-compliances


The persistence of non-compliance is as important as the average number of non-compliances
observed per installation per year. In figure 6(a) this is displayed the total of persistent non-
compliances related to the 126 items observed during inspections (solid bars) and the total
number of inspections executed per year (empty bars) including the first inspection to grant
the first operational authorisation, where persistence cannot be considered. In figure 6(b)
the persistence index is displayed in a normalised way by the total number of inspection
514 C E G R Alves et al

Figure 5. Frequency of all non-compliances of interest observed during annual inspections.

Figure 6. (a) Persistence of the total non-compliances observed during annual inspections.
(b) Frequency of persistence of non-compliances of interest observed in annual inspections.

per year, where the persistence concept can be applied only to installations that have been in
operation for at least 2 years. It is clearly seen that the number of persistent non-compliances
is approximately constant from 2002 up to 2006, being around 45%. This is evidence that
although the regulatory inspection programme has reached its primary goal, there are still some
failures in the licensing process and regulations allowing some installations to persist with the
same non-compliances for several years.

4.3. Annual effective doses


During the inspections the occupational effective doses observed for the last year and for the
last 5 years are checked to verify the compliance with regulatory dose limits for these periods:
20 mSv and 100 mSv, respectively. The investigations carried out by the radiation protection
The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 515

Figure 7. Annual effective dose of all nuclear medicine facilities observed during inspection per
year.

Figure 8. Maximum effective doses observed in nuclear medicine facilities per year.

officer related to some incident or accident are also checked. Figure 7 presents the effective
occupational doses verified during inspections as an average for all installations. The data are
available only from 2000 when this non-compliance started to be reported during inspections.
It can be observed that the annual mean effective dose values are always below the annual
limits but are, in some cases, still above the investigation levels of 6 mSv/year, where the
optimisation of radiological protection procedures is recommended. To achieve that, the
necessary investigation and measurements are checked during the inspections to certify that
they are adequately established.
The maximum effective dose per year is also examined, but this involves a different
approach. If the regulatory dose limits are exceeded, a reactive inspection is carried out to
verify the radiological protection conditions in which this unjustified dose occurred.
Figure 8 shows the maximum effective dose values observed since 2000. It can be seen that
only in 2002 was there no record above 20 mSv. After investigation, it was concluded that the
cause of these high dose values was always an error in the manipulation of sources and patients
or in the source storage system. Here, again, the occurrence can be explained by a failure of
staff training and by an absence of commitment to radiological protection procedures.
Despite the efforts of the regulatory body, the doses database is not yet related to the
facilities yet and access to doses values is by worker identification. As workers usually change
their employment, the task of directly linking personal doses to an specific installation is not
possible. Since 2008, the doses database has been under revision to provide this possibility for
occupational dose control.
516 C E G R Alves et al

5. Conclusions and final remarks

In this paper we defined some non-compliances of interest characterised according to their


importance for radiological protection issues in nuclear medicine facilities. The results indicate
that the regulatory body inspection programme has had some effectiveness in reducing the
frequency of non-compliances over the period 1996–2006.
Some non-compliances require particular attention since they are clear evidence of a lack
of necessary concern for radiological protection, for example non-compliance items associated
with quality control of equipment. It can be concluded that most radiation protection officers
are still not sufficiently well trained to take the responsibility for the management, supervision
and control of a nuclear medicine installation. When this problem is verified during inspection,
radiological protection is considered to be out of control and the facility usually has its supply
of radioactive material stopped by CNEN enforcement.
After the a decline in frequency of non-compliances for many years, a minimum was
observed in 2001. After that some increase in non-compliance has occurred, which can be
assigned to the introduction of some new requirements as the result of an improvement in
the inspection procedure, leading the regulatory authority to be more restrictive regarding the
facilities under control. It was also verified that a large number of installations persist with the
same non-compliances and it is necessary that the regulatory authority plans a list of stricter
actions to enforce a solution.
Until 2006, because of an insufficient number of professionals certified [9] to work as
radiation protection officers in nuclear medicine, CNEN has accepted the nuclear physician
as being responsible for the radiological protection of the installation. Considering also,
in many cases, that the physician was the head of the nuclear medicine department, the
actions concerning radiological protection issues were considered to be of minor importance
in comparison to the medical issues. From 2007, there was a big effort from CNEN to certify
professionals in order to have an adequate number of radiological protection officers in the field
of nuclear medicine [10, 11]. It is expected that the introduction of a professional dedicated to
supervise and execute radiological protection in each facility will reduce the number of non-
compliances. An evaluation of this new approach will be performed at the end of 2009, when a
new set of statistical data will become available for investigation.
The manipulation of radioactive material is another procedure that is a matter of concern.
As a large number of installations presenting this non-compliance are observed, one can directly
infer that their staff are not properly qualified or trained. Brazil is a country of continental
dimensions with great differences in social and economic conditions between regions; besides,
the main available training courses in radiological protection are concentrated in the southeast
of the country. Therefore, a proposal to develop some practical technical courses travelling
throughout the country could be a means to improve the situation in this field.
Also, the development of a doses database integrated with other information about facility
licensing will improve occupational exposure control in the country.
As a final remark, although several points of continuous improvement in the licensing
process have been implemented recently by CNEN, with constant technological advances in
medical physics new approaches to the licensing process for radiation installations with new
equipment such as PET or PET/CT should be introduced. The CNEN inspection group is
already working on this task and soon new data concerning this subject will be presented.

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The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 517

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